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Trial registered on ANZCTR


Registration number
ACTRN12615000487516
Ethics application status
Approved
Date submitted
16/03/2015
Date registered
15/05/2015
Date last updated
19/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the effect of oral curcumin on lymphocyte count in patients with clinical stage 0/1 chronic lymphocytic leukemia.
Scientific title
A pilot study of the effect of oral curcumin on lymphocyte count in patients with clinical stage 0/1 chronic lymphocytic leukemia.
Secondary ID [1] 286359 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stage 0/1 chronic lymphocytic leukemia 294493 0
Condition category
Condition code
Cancer 294797 294797 0 0
Leukaemia - Chronic leukaemia
Alternative and Complementary Medicine 294865 294865 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Curcumin, derived from the spice turmeric, has anticancer and anti-inflammatory properties. Curcumin will be administered orally at a dose of 2g/day. Patients will be monitored at 2 monthly intervals for a period of six months. Blood samples will be collected at each visit. Lymphocyte count, surface leukocyte markers,CRP and ESR, liver function will be assessed by blood tests. Compliance will be ascertained by questioning the patient.
Intervention code [1] 291420 0
Treatment: Other
Comparator / control treatment
This is a pilot study of a GRAS nutraceutical and thus no comparator group is involved in the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294549 0
A change in absolute lymphocyte count as assessed by serum assay.
Timepoint [1] 294549 0
assessment will be made at baseline, 2, 4 and 6 months
Secondary outcome [1] 313601 0
a change in surface leukocyte markers as determined by blood tests.
Timepoint [1] 313601 0
assessment will be made at baseline, 2, 4 and 6 months.
Secondary outcome [2] 314622 0
CRP and ESR as determined by blood tests
Timepoint [2] 314622 0
baseline, 2, 4 and 6 months
Secondary outcome [3] 314623 0
liver function as determined by blood tests
Timepoint [3] 314623 0
baseline, 2, 4 and 6 months

Eligibility
Key inclusion criteria
Male or female patients over the age of 40 who have been diagnosed with stage 0/1 chronic lymphocytic leukemia (absolute lymphocyte count > 20x10 (9)lymphocytes/L).
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Patients who are being actively treated.
2)Requirement for major surgery
3) Patients with diabetes
4) Patients on warfarin
5) Patients with GORD

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3566 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 9372 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 290929 0
Hospital
Name [1] 290929 0
Researchers Department
St George Hospital
Address [1] 290929 0
St George Hospital
Gray street
Kogarah
NSW
2217
Country [1] 290929 0
Australia
Primary sponsor type
Other
Name
Southern Sydney Haematology
Address
1-5 Derby street, Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 289615 0
Hospital
Name [1] 289615 0
Department of Endocrinology
Prichard Wing
St George Hospital
Address [1] 289615 0
Prichard Wing
St George Hospital
Gray street
Kogarah
NSW
2217
Country [1] 289615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292536 0
South Eastern Sydney Local Health District
Ethics committee address [1] 292536 0
Room G71, East Wing
Edmund Blacket Bldg
Prince of Wales Hospital
Cnr High and Avoca streets
Randwick
NSW
2031
Ethics committee country [1] 292536 0
Australia
Date submitted for ethics approval [1] 292536 0
25/06/2013
Approval date [1] 292536 0
22/10/2013
Ethics approval number [1] 292536 0
12/094

Summary
Brief summary
This study aims to determine if curcumin can delay progression of chronic lymphocytic leukemia in patients with early disease. Who is it for? You may be eligible join this study if you are a patient over the age of 40 who has been diagnosed with stage 0/1 chronic lymphocytic leukemia (absolute lymphocyte count > 20x10^9 lymphocytes/L). Trial details All participants in this trial will be given curcumin (derived from the spice turmeric) orally at a dose of 2g/day for 6 months. Participants will be assessed by blood test every 2 months over the 6 month study period in order to determine treatment response such as absolute change in lymphocyte count.
Trial website
Trial related presentations / publications
Publication: The effect of curcumin (as Meriva) on absolute lymphocyte count (ALC), NK cells and T cell populations in patients with stage 0/1 chronic lymphocytic leukemia. Jounal of cancer therapy,2015,6,566-571.
Public notes

Contacts
Principal investigator
Name 55798 0
Dr Terry Golombick
Address 55798 0
level 3
Prichard Wing
St George Hospital
Gray street
Kogarah
NSW
2217
Country 55798 0
Australia
Phone 55798 0
+61 2 91132767
Fax 55798 0
Email 55798 0
terry.golombick@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 55799 0
Dr Terry Golombick
Address 55799 0
level 3
Prichard Wing
St George Hospital
Gray street
Kogarah
NSW
2217
Country 55799 0
Australia
Phone 55799 0
+61 2 91132767
Fax 55799 0
Email 55799 0
terry.golombick@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 55800 0
Dr Terry Golombick
Address 55800 0
level 3
Prichard Wing
St George Hospital
Gray street
Kogarah
NSW
2217
Country 55800 0
Australia
Phone 55800 0
+61 2 91132767
Fax 55800 0
Email 55800 0
terry.golombick@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary